Home NDC 58466-109 78 x 36 SPF 30 Active
Product NDC 58466-109
11-digit product format 584660109
Labeler code 58466
Product ID 58466-109_1c2b73fd-1c52-4db3-982e-d937c04ceeac
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Dermazone LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance ZINC OXIDE
Active strength .2 g/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58466-109-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58466-109-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58466-109-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58466-109-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58466-109-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58466-109-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58466-109-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 78 x 36 SPF 30 Active
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .2 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58466-109-03 78 x 36 SPF 30 Active 96 g in 1 TUBE CREAM 96 2 58466-109-03 78 x 36 SPF 30 Active 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58466-109 78 X 36 SPF 30 ACTIVE (ZINC OXIDE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 Current NDC, 2 package rows 20231001_96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 103 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f5242c7d-09e1-4141-8de1-a89bd7981ca6 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc9 2025-12-22 Warnings Exact identifier application number: M020 Go Daily Defense Soothing Mineral Face Sunscreen SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. fd040893-b1e5-783f-e053-6294a90ac216 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. 0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95 2025-12-22 Warnings Exact identifier application number: M020 GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f3bb46e8-a9a5-b184-e053-2995a90afca7 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - POUT PROTECTOR SPF-15 ZINC OXIDE SOLARA SUNCARE, INC. ab6a326d-3b93-4122-a9f2-05e8203d31ef 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - FORTUNE TELLER SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. f434de33-5da8-57ef-e053-2a95a90a8502 2025-12-22 Warnings Exact identifier application number: M020 SPF 50 Kids Sunscreen Equate AVOBENZONE, HOMOSALATE, OCTOCRYLENE Walmart Inc 46919f43-2dee-57b1-e063-6294a90a15eb 2025-12-22 Warnings Exact identifier application number: M020 SPF 30 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walmart Inc 46919f45-e3f3-4ed0-e063-6294a90a9835 2025-12-22 Warnings Exact identifier application number: M020 Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the face HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451bb734-d54d-e24e-e063-6394a90a1adb 2025-12-21 Warnings Exact identifier application number: M020 CabanaClear Illuminating SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE NAKED SUNDAYS PTY LTD 47d1a39e-f645-c33d-e063-6394a90ad1ef 2025-12-21 Warnings Exact identifier application number: M020 THE MELT MIST Sheerest Mineral Mist Suncare for Body TITANIUM DIOXIDE, ZINC OXIDE Dune Suncare, Inc. 465d3277-7798-512a-e063-6294a90a2065 2025-12-20 Warnings Exact identifier application number: M020 THE SLIP Invisible Cooling Suncare for Face and Body AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Dune Suncare, Inc. 465e1ba2-e967-edb9-e063-6294a90aa31c 2025-12-20 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7287078e-67ff-41fe-bc8d-59b2146f5dc9 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b6095639-e2ee-418e-b4f1-e59da1bd9216 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8c6466a6-4f11-4210-bb02-eb31c15984cd 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 07f8282b-047b-4be1-8779-39ed5dd6fb5d 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5a8c67c1-aeba-490d-8347-a30916efcf3b 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 739450b0-8cd7-41de-8cd0-1827e02478c6 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 08b0e056-583a-474b-aaaa-ecea05703044 2025-12-19 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58466-109-03 58466010903 1 TUBE in 1 CARTON (58466-109-03) / 96 g in 1 TUBE 1 tube 2023-10-01 No No Current